Impact of ORBIS on public policies – open consultations of draft regulatory documents and the Pharmaceutical Strategy for Europe
Keywords:pharmacy, biopharmacy, pharmacokinetics, bioequivalence, open consultations, regulatory guidelines
Public policies and regulations strongly influence research and manufacturing in pharmaceutical sector. Therefore, it is of critical importance that these policies and regulations are of high quality as well as appropriately balanced between general rules and detailed solutions. The process of public consultations prolongs adoption of novel documents. On the other hand, comments from different stakeholders like academia, industry, public administration and patients allow 360-degree critical evaluation of the document and a better understanding of the topic.
This mini-review summarizes the contributions of numerous members of ORBIS project team in open consultations of draft regulatory documents published by European Medicines Agency (EMA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ORBIS project feedback on the Pharmaceutical Strategy for Europe is also presented.
ORBIS project members contributed to open consultations of two ICH draft guidelines, and three EMA draft documents. ORBIS project was also active during the European Commission’s efforts to develop Pharmaceutical Strategy for Europe.
The interaction between representatives of academic and industrial sectors allowed to form balanced comments. We hope that this paper will inspire more researchers to participate in future open consultations on public policies.
EMA, Reflection paper on investigation of pharmacokinetics and pharmacodynamics in the obese population (EMA/CHMP/535116/2016). https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-investigation-pharmacokinetics-pharmacodynamics-obese-population_en.pdf. Access date: 17.07.2023
EMA, Draft guideline on quality and equivalence of topical products (CHMP/QWP/708282/2018). https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-equivalence-topical-products_en.pdf Access date: 17.07.2023
EMA, Draft Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance (EMA/CHMP/257298/2018). https://www.ema.europa.eu/en/documents/scientific-guideline/lapatinib-film-coated-tablet-250-mg-product-specific-bioequivalence-guidance-first-version-2nd-draft_en.pdf Access date: 17.07.2023
ICH, Draft guideline ICH guideline M10 on bioanalytical method validation (EMA/CHMP/ICH/172948/2019).https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-m10-bioanalytical-method-validation-step-2b_en.pdf Access date: 17.07.2023
ICH, Draft Guideline M13A on bioequivalence for immediate-release solid oral dosage forms (EMA/CHMP/ICH953493/2022). https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m13a-bioequivalence-immediate-release-solid-oral-dosage-forms-step-2b_en.pdf Access date: 17.07.2023
European Commission, Pharmaceutical Strategy for Europe. https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe_en Access date: 16.07.2023
EMA, Overview of comments received on 'Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance' (EMA/CHMP/257298/2018) https://www.ema.europa.eu/documents/comments/overview-comments-received-lapatinib-film-coated-tablet-250-mg-product-specific-bioequivalence/2nd-draft_en.pdf Access date: 16.07.2023
EMA, Overview of comments received on ICH guideline M10 on bioanalytical method validation (EMA/CHMP/ICH/172948/2019) https://www.ema.europa.eu/documents/comments/overview-comments-received-draft-ich-guideline-m10-bioanalytical-method-validation-step-2b_en.pdf Access date: 16.07.2023
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Feedback from ORBIS Project Consortium (H2020-MSCA-RISE-2017) on “Pharmaceuticals – safe and affordable medicines (new EU strategy)” https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12421-Pharmaceutical-Strategy-Timely-patient-access-to-affordable-medicines/F536455 Access date: 17.07.2023
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